Surgical probe and apparatus with improved graphical display

ABSTRACT

An apparatus for detecting a locating medium in tissue includes a probe, and a console. The probe includes a handle and a detector disposed on a distal end of the probe. The console is in communication and includes a display. The display has a first graphical representation and a second graphical representation. The first graphical representation is configured to depict a count real-time count based on a signal from the detector. The second graphical representation is configured to depict a target count.

PRIORITY

This application claims priority to U.S. Provisional Patent App. No.62/806,949 entitled “Surgical Probe and Apparatus with ImprovedGraphical Display,” filed on Feb. 18, 2019, the disclosure of which isincorporated by reference herein. This application is further acontinuation-in-part of U.S. Ser. No. 16/659,802 entitled “SurgicalProbe and Apparatus and System and Method of Use Thereof,” filed on Oct.22, 2019, which is a continuation of U.S. Ser. No. 15/963,152 entitled“Surgical Probe and Apparatus and System and Method of Use Thereof,”filed Apr. 26, 2018, now issued as U.S. Pat. No. 10,485,497 on Nov. 26,2019, which is a continuation of International App. No.PCT/US2016/058907 entitled “Surgical Probe and Apparatus and System andMethod of Use Thereof,” filed on Oct. 26, 2016, which claims priority toU.S. Provisional Patent App. No. 62/247,082, entitled “Surgical Probeand Apparatus and System and Method of Use Thereof,” filed on Oct. 27,2015, the disclosures of which are incorporated by reference herein.

BACKGROUND

Procedures for the treatment of cancer generally have been based uponthe natural history of tumor spread, and thence, upon operative andnon-operative options available to the physician. Operative optionsgenerally have looked to the physical identification and surgicalresection of tumor. A variety of techniques have been brought to bear inthe art with the purpose of aiding the surgeon in detecting andlocalizing neoplastic tissue as part of this surgical procedure.(“Neoplastic tissue,” for the present purposes, often is referred to ascancerous tissue, though malignant tumor and malignant tumor cells alsoare found in the terminology of the art. The term “neoplastic tissue”includes all of these.) Typically, large tumor is readily located by thesurgeon by visualization at the operating theater, and, in particular,through palpation, i.e., the feel of tumor as opposed to that of normaltissue. To achieve operative success, however, it is necessary for thesurgeon to somehow locate “occult” tumor, i.e., tumor which cannot befound by the conventional surgical procedures of sight and feel. Failureto locate and remove such occult tumor generally will result in thecontinued growth of cancer in the patient, a condition often referred toas “recurrent” cancer.

A method for locating, differentiating, and removing neoplasms uses aradiolabeled antibody injected into the patient. Once injected, suchantibodies are known to accumulate in neoplastic tissues at a higherconcentration than in normal tissue. A portable radiation detectionprobe is employed by a surgeon intraoperatively in order to detect sitesof radioactivity. Because of the proximity of the detection probe to thelabeled antibody, the faint radiation emanating from occult sitesbecomes detectable, for example, in part because of the inherentapplication of the approximate inverse square law of radiationpropagation. The procedure is now known as radioimmunoguided surgery, orRIGS® (RIGS being a registered trademark of Neoprobe Corporation ofDublin, Ohio).

Similarly, Intraoperative Lymphatic Mapping (ILM) may be utilized tostudy the effect of neoplastic tissue on a patient's lymphatic system.The lymphatic system provides a vital function in fighting disease;however, this intricate network also creates an ideal pathway for cancercells to travel and spread. For example, certain solid-tumor cancerssuch as breast, melanoma, lung, colorectal and head-and-neck cancerfrequently spread via the lymphatic system.

The spread of cancer to the patient's lymph nodes is typicallydetermined by examination of the nodes along the likely drainage path bypathology to determine if tumor cells are present. It is not uncommonfor a surgeon to remove most of the lymph nodes in the area surroundinga solid tumor. This radical and often unnecessary procedure causes alarge number of patients to experience significant complicationsfollowing surgery.

ILM overcomes many of these drawbacks. In an ILM procedure, a tracingagent such as a radioactive, magnetic, fluorescent, microwave, radiofrequency emitting, or other material is injected at the site of theprimary tumor. Following injection, the tracing agent follows the likelydrainage path of the tumor to the initial lymph node or nodes that thetumor may be draining to, referred to as the “sentinel node(s).” Adetection device such as a gamma radiation, magnetic field, radiofrequency, or other detection device is used to detect the tracingagent. Since the lymph nodes are connected, oncologists believe that ifthe sentinel nodes show no sign of malignancy, then the downstream nodesin the pathway are likely to be clear of disease, as well. As such, theremoval of other nearby lymph nodes would be deemed clinicallyunnecessary. Therefore, the ability to rapidly locate and biopsysentinel nodes provides vital information to the physician indetermining if the cancer has spread or if it is localized to the siteof the primary tumor.

Surgical radiation detection instrumentation is comprised generally of ahand-held probe which is in electrical communication with a controlconsole via a flexible cable. This control console is typically locatedwithin the operating room facility but out of the sterile field, whilethe hand-held probe and forward portions of its associated cable arelocated within that field. The hand-held radiation detecting probe isrelatively small and performs in conjunction with a detector such as acadmium zinc telluride (CZT) crystal. Details of such instrumentationmay be found in commonly owned U.S. Pat. No. 4,782,840, the disclosureof which is expressly incorporated herein by reference.

A drawback of current surgical radiation detection instrumentation isthe flexible cable extending between the probe and the control console.If the cable is too short, it tends to limit the user's flexibility inpositioning the probe. Conversely, if the cable is too long it maybecome entangled with other instrumentation and equipment. Furthermore,a cable that is not adequately or appropriately sterilized or draped isa potential source of contamination of the operative field.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings and detailed description that follow are intended to bemerely illustrative and are not intended to limit the scope of theinvention as contemplated by the inventors.

FIG. 1 shows a system for detecting and locating sources of radiationemission comprising a probe and an associated instrumentation consoleaccording to an embodiment of the present invention;

FIG. 2 is a block diagram of the probe of FIG. 1;

FIG. 3 is a block diagram of the instrumentation console of FIG. 1;

FIG. 4 is a partial schematic diagram of the probe of FIG. 1;

FIG. 5 shows a system for detecting and measuring a material within ahuman body;

FIGS. 6A and 6B are flowcharts of exemplary steps that may be performedwith the system of FIG. 5 to display measured signals;

FIG. 7 shows a system for detecting and measuring magnetic fields withina human body;

FIG. 8 is a graph illustrating a relationship between magnetic strengthand temperature; and

FIG. 9 is a flowchart of exemplary steps that may be performed tooperate the system of FIG. 7 based on temperature.

DETAILED DESCRIPTION

The general arrangement of a system (10) for detecting and locatingsources of radiation emission is shown in FIG. 1 according to anembodiment of the present invention. System (10) comprises a probe (12)that is in wireless communication with an associated instrumentationconsole (14). Further details of each are provided below.

A. Probe

With reference to FIGS. 1 and 2, probe (12) includes a housing (16)containing in pertinent part a detector (18), a preamplifier (20), acontroller (22) and a probe wireless data link (24). Probe (12) ispowered by a not-shown power source, such as a disposable orrechargeable battery.

Detector (18) generates a low-level electrical signal (26) correspondingto the gamma radiation count of tissue proximate the detector. Detector(18) may be made from cadmium zinc telluride or any other semiconductormaterial suitable for detecting photon radiation. More broadly, detector(18) may be made from any suitable type of crystal that is responsive togamma radiation emitted by radiolabeled antibodies. For example,detector (18) may comprise cadmium-telluride crystals with or without analloy, for example, with zinc. Such alloys for the present descriptionmay generally and interchangeably be referred to as “Cadmium-telluride,”“CdTe” and “CZT.” Details of exemplary CZT crystals may be found incommonly assigned U.S. Pat. Nos. 6,218,669, 6,191,422, 5,495,111 and5,441,050, the entire contents thereof being incorporated herein byreference thereto.

Alternatively, detector (18) may be a scintillating device. Thescintillating device may be any type of particle or radiation detectornow known or later developed for detecting and counting scintillationsproduced by ionizing radiation including, but not limited to, cesiumiodide. For example, detector (18) configured as a scintillating devicemay operate through emission of light flashes that are detected by aphotosensitive device, such as a photomultiplier or a silicon PIN diode.

Preamplifier (20) receives and amplifies the low-level electrical signal(26) generated by detector (18) to a corresponding output electricalsignal (28) of greater magnitude (i.e., voltage and current).Preamplifier (18) may also supply an electrical bias voltage (30) todetector (18) to effect charge migration in the detector when it isexposed to gamma radiation. Details of exemplary preamplifiers may befound in commonly assigned U.S. Pat. Nos. 6,222,193 and 6,204,505, theentire contents thereof being incorporated herein by reference.

Controller (22) receives the output electrical signal (28) frompreamplifier (20) and analyzes the output electrical signal to derivegamma data corresponding to the amount of gamma energy detected bydetector (18). In some embodiments the gamma data may be in the form of“counts” relating to the number of detected photon radiationimpingements. Further details may be found in commonly assigned U.S.Pat. No. 4,889,991, the entire contents thereof being incorporatedherein by reference thereto. Controller (22) may also be configured witha control switch (23) to allow a user of probe (12) to set predeterminedoperating parameters of the probe including, without limitation, areal-time radiation target count and a time-interval accumulated count,and calibration/test. Parameters may be selected by actuating controlswitch (23) for a predetermined period of time, or by actuating thecontrol switch a predetermined number of times within a predeterminedperiod of time.

Controller (22) may be a digital microprocessor-based control unitconfigured to operate according to a predetermined control logic toprovide control signals for controlling the operation of probe (12).Alternatively, controller (22) may comprise other types of digital-basedarchitectures utilizing, for example, a computer, microcontroller,programmable logic device and the like. The control logic of controller(22) may be defined by a set of predetermined instructions, such as acomputer program or “fuzzy logic.” Controller (22) may also compriseanalog circuitry in whole or in part.

Probe wireless data link (24) (hereinafter termed “probe link (24)”) isconfigured for operation in conjunction with an associatedinstrumentation console data link (32) of console (14) to transfer databetween the probe and the console. Probe link (24) may be implemented inany form now known or later invented utilizing, without limitation,radio frequency (RF), visible light, infra-red light, sonic andultrasonic links and any conventional type of analog or digitalmodulation including, without limitation, amplitude modulation,frequency modulation, phase shift keying and frequency shift keying.Telecommunication protocols such as the BLUETOOTH® standard aspromulgated by the Bluetooth Special Interest Group, Inc. (SIG) may alsobe employed. An example embodiment employing a BLUETOOTH protocol isfurther described below. Alternatively, a proprietary communicationprotocol may be utilized.

B. Instrumentation Console

With reference to FIGS. 1 and 3, instrumentation console (14) includesan integral instrumentation console wireless data link (32), a display(34), a universal asynchronous receiver/transmitter (UART) (36), areceiver (38), a signal processor (40), a power supply (42) and a powerinput (44).

Integral instrumentation console wireless data link (32) (hereinaftertermed “console link (32)”) is integral to, and contained by, a housing(46) of console (14). Console link (32) is configured for operation inconjunction with probe link (24) to transfer data between the probe (12)and instrumentation console (14). Console link (32) may be implementedin any form now known or later invented utilizing, without limitation,radio frequency (RF), visible light, infra-red light, sonic andultrasonic links and any conventional type of analog or digitalmodulation including, without limitation, amplitude modulation,frequency modulation, phase shift keying and frequency shift keying.Telecommunication protocols such as the BLUETOOTH® standard aspromulgated by the Bluetooth Special Interest Group. Inc. (SIG) may alsobe employed. A standard Serial Port Protocol (SPP) software package mayalso be included with console link (32). Alternatively, a proprietarycommunication protocol may be utilized.

UART (36) is a data communication interface and converter. UART (36)converts data received by console link (32) to a serial data stream andforwards the serial data stream to receiver (38). Likewise, serial datagenerated by receiver (38) may be forwarded to console link (32) viaUART (36) and converted to another data format for transmission to probe(12) via links (24), (32). The serial data stream employed inconjunction with UART (36) may be configured in an Electronic IndustriesAlliance (EIA) serial data format, such as RS-232, RS-422 and RS-485, ormay be a proprietary format.

Receiver (38) receives the serial data stream from UART (36) andconverts the serial data stream to electrical display signals (48)having predetermined voltage, current and frequency values correspondingto the content of the data stream. Electrical display signals (48) arecoupled to display (34).

Receiver (38) may include a digital microprocessor-based control portionconfigured to operate according to a predetermined control logic toprovide control signals for controlling the operation of instrumentationconsole (14). Alternatively, receiver (38) may comprise other types ofdigital-based architectures utilizing, for example, a computer,microcontroller, programmable logic device and the like. The controllogic of receiver (38) may be defined by a set of predeterminedinstructions, such as a computer program or “fuzzy logic.” In stillother embodiments receiver (38) may be partially or wholly comprised ofanalog circuitry. Receiver (38) may incorporate, without limitation, anyor all of the gamma detection features discussed in commonly assignedU.S. Pat. Nos. 6,272,373, 6,259,095, 6,144,876 and 5,732,704, the entirecontents thereof being incorporated herein by reference thereto.

Signal processor (40) may be configured to execute functions relating toanalyzing, interpreting and manipulating the serial gamma data.Functions executed by signal processor (40) include, without limitation,filtering, smoothing, noise reduction and thresholding. For example,signal processor (40) may be adjusted by a user of system (10) to set athreshold value of the gamma data such that data having a value belowthe select threshold is ignored by receiver (38) and not provided todisplay (34) in the form of electrical display signals (48). A dynamicpitch mode may be selected wherein a baseline value is stored and usedas a threshold. Alternatively, a binary pitch mode may be selectedwherein a baseline value is stored for comparison, to determine whethera difference in detected radioactivity between a reference (such asbackground tissue) and a radiation source (such as target tissue) isstatistically significant. Signal processor (40) may be configured foruse with analog or digital signals, or both.

Display (34) receives electrical display signals (48) and converts thedisplay signals to a visually perceivable indication corresponding tothe serial data stream. Display (34) may be any type of visual displaynow known or later developed including, without limitation, cathode raytubes, fixed-format liquid crystal displays, plasma displays, activematrix liquid crystal displays, and light emitting diode displays.Display (34) may be monochromatic, color or a combination thereof, andmay include a backlight.

Instrumentation console (14) may optionally include an aural outputsubsystem (50) configured to generate an aural signal corresponding tothe gamma data in a predetermined manner. For example, the frequencyand/or amplitude of the aural signal may be made proportional to a gammacount corresponding to the low-level electrical signal (26) generated bydetector (18).

Power supply (42) may be any type of linear or switching-typearrangement for converting mains AC power to one or more predeterminedAC and DC voltages and currents required by the components ofinstrumentation console (14).

Power input (42) may be configured to establish a select AC mains powerinput, such as 110 or 220 volts AC. Power input module (42) may alsoinclude over-voltage protection circuitry, such as transientsuppressors, and over-current protection devices, such as fuses andcircuit breakers.

C. System Operation

With reference now to FIGS. 1 through 4 together, in operation system(10) detector (18) of probe (12) is electrically biased by bias voltage(30) coupled thereto. Gamma radiation (52) emitted from a source (54) ofphoton emission radiation impinges upon detector (18), causing thedetector to generate a low level electrical signal (26) corresponding topredetermined characteristics of the detected gamma radiation, such asthe number of photon impingements or radiation count (hereinaftergenerally termed “gamma data”). Preamplifier (20) receives and amplifieslow-level electrical signal (26) generated by detector (18) to acorresponding output electrical signal (28) of greater amplitude, theoutput electrical signal likewise corresponding to and representing thegamma data.

Controller (20) receives the gamma data from preamplifier (20) viaoutput electrical signal (28). Controller (20) converts the gamma datato a “message” (56) having a predetermined analog and/or digital format,the message containing information relating the gamma data in saidformat. Message (56) is periodically transmitted as a component of aprobe output signal (58) transmitted by probe link (22) to console link(24). In one embodiment of the present invention message (56) istransmitted about every fifty milliseconds. Message (56) contains astart transmission character, a message type character, the gamma data(two bytes), and a checksum byte (summing all other message bytes).Probe output signal (58) may also include error correction and automaticre-transmission capability to ensure the quality of the datatransmission. If BLUETOOTH technology is employed, links (22), (24) mayinclude a frequency hopping technique to avoid interference with otherwireless devices.

A self-correction scheme is preferred for probe output signal (58). Ifprobe output signal (58) lacks such self-correction, a stronger messagecheck such as a 16-bit cyclic redundancy check, or CRC may be used.Furthermore, if probe output signal (58) lacks automaticre-transmission, a bidirectional transmitter-receiver handshake schememay be utilized wherein a console output signal (60) issued wirelesslyby console link (32) transmits a confirmation message (62) to probe link(24), the confirmation message being forwarded to controller (22) by theprobe link for error-checking comparison with message (56).

Console link (24) forwards message (56) to UART (36), which converts themessage to serial format and forwards the message to receiver (38).Receiver (38) validates message (56) using a checksum byte. Once themessage is validated, the received gamma data is compared against thelast counter value and a difference is calculated. Any 16-bit counteroverflow is also taken into account. If the gamma data is in the form ofan absolute gamma count a difference calculation is desirable.

The gamma count value is synchronized to a highly accurate internal fivemillisecond time interval by receiver (38), each time interval beingtermed a “bin.” This synchronization is accomplished so that a stable,accurate gamma data count provided to display (34) in the form ofelectrical display signals (48), the electrical display signals beingconverted by the display to a corresponding visually perceivable imagerepresentative of the gamma data. Incoming gamma data values areaveraged by receiver (38) over the next ten “bins” to derive a smoothedgamma data count. The smoothing operation is preferably configured sothat it does not add or remove any gamma counts to the resulting values.

If messages (56) are being lost (i.e., wireless out of range,transmitter turned off, or wireless interference), the gamma data valuesdisplayed by display (34) may be set to zero. If no messages aredetected for a predetermined minimum period of time, such as for fiveseconds, receiver (38) may determine that probe output signal (58) hasbeen lost and provides predetermined electrical display signals (48) todisplay (34) such that the display visually indicates this condition toa user of system (10) in a predetermined manner, such as with a “NOSIGNAL” annunciation.

In some embodiments of the present invention receiver (38) may becoupled to signal processor (40). Signal processor may be configured toexecute some or all of the previously noted functions relating toanalyzing, interpreting and manipulating the serial gamma data.

In some embodiments of the present invention aural output subsystem (50)may be used in conjunction with display (34), or instead of the display.Aural output subsystem (50) may be configured to generate an auralsignal corresponding to the gamma data in a predetermined manner. Forexample, the frequency and/or amplitude of the aural signal may beproportional to the gamma count.

In previous gamma detection diagnostic systems analog signals from aprobe were coupled to a console through a flexible cable. The assigneeof this application has previously improved upon the art by developing awireless link between a probe and a console, but that configurationrequired an external adapter coupled to a data interface connector ofthe console. The external adapter is subject to being lost or misplaced,or could be accidentally unplugged, thereby disrupting diagnosticactivities that often have been planned well in advance of theprocedure. Furthermore, repetitive insertion and removal of the externaladapter to the data interface of the console can generate wear of matingconnectors on the adapter and console, resulting in intermittent orbroken connections. The present invention, which includes a probe (12)having a probe link (22) that communicates with a corresponding consolelink (24) that is integral to a console (14), represents a significantimprovement in the art.

D. Multi-Display Instrumentation Console

FIG. 5 shows a system (100) for detecting radiation, magnetic fields,and other signals. A probe (102) may be used similarly to the probe(12), and may be moved about a patient in order to detect and measurethe strength of a substance or material injected in the patient during aprocedure such as those described herein. A probe tip (104) may containa sensor configured to detect magnetic field strength, gamma ray orother radiation, incoherent and coherent light, microwave, radiofrequency, fluorescence, and other conditions or signals associated withor emitted by an injected material, substance or other tracing agent. Asone example, a tracing agent might be a magnetic material reduced into apowder or grit and mixed with a carrier liquid or fluid.

An instrumentation console (101) includes a display (106) configured todisplay one or more characteristics measured by the probe (102). Theinstrumentation console (101) may have one or more characteristics orfeatures as described above in the context of the instrumentationconsole (14). The display (106) may show any of the information orfeatures described herein, and may also show a current measurement(108), a max measurement (107), and a threshold (or target) measurement(110). The current measurement (108) may be the strength of a signal orfield currently detected by the probe (102).

The max measurement (107) may be the maximum measured strength of asignal or field during a particular use of the probe (102) (e.g., duringa procedure the highest measured strength may be 180, and may beautomatically stored until replaced by a higher measured strength). Thethreshold measurement (110) may be automatically determined based uponthe current measurement (108) or the max measurement (107), and may bedetermined as a static or other proportion of the measured value. Forexample, the threshold measurement (110) may be determined as 10% of thecurrent measurement (108), and may be saved and displayed when athreshold button (112) is pressed by a user during a procedure.Percentages might be statically configured for each device, or may bevariably configured by a user for each device or procedure performedwith a device, or may be automatically configured based upon a selectionof a type of procedure, or may be set or configured in other similarways. This may be useful to set a detection threshold during a procedureso that a user of the probe (102) may easily determine when they havereached a portion of the patient's body that is unlikely to havereceived substantial portions of the injected material. Theinstrumentation console (101) may also include a voice detection feature(111) such as a microphone and software for interpreting voice commandsfrom a user, and that may be used similarly to the threshold button(112) or any other control. The voice detection feature (111) andthreshold button (112) may be used in addition to or as an alternativeto other control features described herein, and may be combined withother control features such as foot pedals, motion controls, inductivecontrols, and other control types that may be combined with one or moreof the system (100), instrumentation console (101), or probe (102).

In some examples, threshold measurement (110) can be shown as a simplenumerical representation of a number of counts over a predeterminedperiod of time (e.g., counts per second). In other examples, thresholdmeasurement (110) can be shown as a graphical representation depictingthe relationship between threshold measurement (110) and currentmeasurement (108) and/or max measurement (107). By way of example only,such a graphical representation may be in the form of a color coded bargraph that changes in color intensity as current measurement (108)approaches threshold measurement (110). In still other examples,threshold measurement (110) can be shown as both a numericalrepresentation and a graphical representation concurrently. In addition,it should be understood that in some examples one or more components ofdisplay (106) can be optionally incorporated into a portion of probe(102). For instance, in some examples threshold measurement (110),current measurement (108), max measurement (107) and/or a graphicalrepresentation of one or more such measurements can be integrated withina portion of probe (102) such as on a handle.

FIG. 6A shows an example of the operation of the system (100), thesystem may measure (300) the strength of a signal and display (302) thatstrength as the current measurement (108). When a user input is received(304), such as an actuation of the threshold button (112), a thresholdmay be determined (306) as a percentage of the current measurement(108), and then displayed (308).

FIG. 6B shows another example of the operation of the system (100), thesystem may measure (310) the strength of a signal and, when thatstrength is a maximum for that session or use, display (312) that maxstrength as the max measurement (107). When a user input is received(314), such as an actuation of the threshold button (112), a thresholdmay be determined (316) as a percentage of the max measurement (107),and then displayed (318).

E. Magnetic Probe System

FIG. 7 shows a system (120) having one or more of the features orfunctions of the system (10) and system (100). The system (120) includesa probe (122) and probe tip (124) usable to detect and measure thestrength of an injected material or substance. The probe (122) may alsoinclude a temperature sensor (134) proximate to the probe tip (124) andconfigured to detect the temperature of the surrounding area (e.g., aprocedure room, patient tissue). The system (120) may also include adisplay (126) configured to display a current measurement (128), maxmeasurement (127), and threshold measurement (130), as well as a setthreshold button (132), as described in the context of the system (100).

The probe tip (124) may be implemented as a sensor configured to detectmagnetic field strength, which may be used to detect the movement ofmagnetic particles that have been injected into a patient. Magneticfield detection in this manner may be influenced by the temperature ofthe magnets. For example, FIG. 8 shows a graph (200) illustrating arelationship between magnetic strength and temperature. A y-axis of thegraph (200) shows a number of magnetic washers or elements picked up bya certain magnet, while the x-axis shows a temperature of the magnet inCelsius. The graph lines (202, 204, 206, 208, 210) each show the resultsfor a different type of magnet at various temperatures.

To account for variations in magnetic field detection as a result oftemperature, the temperature sensor (134) may be used to detect thetemperature of the patient and calibrate the magnetic field detectionbased thereon. FIG. 9 shows an example of the system (100) calibratingmagnetic detection in this manner. The temperature may be measured (300)using the temperature sensor (134). In some implementations, the system(120) may verify (332) that the probe (122) is at an operationaltemperature. Where the probe (122) is too cold (e.g., such as where ithas been stored in a cold area) or too hot, the system (120) may preventused of the probe until it reaches acceptable operational temperatures.Once operational, a strength of the magnetic field may be measured(334), and the measured temperature and measured field strength may beused to determine (336) a modified or calibrated measured strength,which may then be displayed (338).

While this invention has been shown and described with respect to adetailed embodiment thereof, it will be understood by those skilled inthe art that changes in form and detail thereof may be made withoutdeparting from the scope of the claims of the invention. Any one or moreof the following examples may be fully or partially combined with eachother as described herein.

Example 1

A surgical apparatus for locating lymph nodes for selective removalwhich includes a display, processor, GUI, memory, proximity sensor andprobe. The proximity sensor located in the probe senses the strength ofthe signal from the source and continuously displays a strengthindicator in realtime. The strength indicator could include a numericalvalue and bar indicator. It could also include sound. The apparatusincludes a button on the front panel (either inside the display screenor outside of it in the housing) or foot pedal that when pressed willdisplay a 10% (preselected secondary node threshold) of the currentstrength indicator value and display it on a separate part of the screenon a permanent basis until the same button or foot pedal is pressedagain.

Example 2

A surgical apparatus that displays two values (max count value andthreshold value (10% of the max count value)) on the display in additionto the realtime updating strength indicator, with the two valuesconfigured to be automatically updated as the probe is being used.

Example 3

A surgical apparatus configured to set a max value based upon an inputfrom a foot pedal or a voice activation, to cause the console to saveand display that value under the max count value as well as thethreshold value, wherein the threshold value may be 10% of the setvalue, and further configured to clear one or more values based on afurther voice command or foot pedal input.

Example 4

A surgical apparatus that allows a user to program secondary nodethreshold percentage, and configured to default to 10%, but beprogrammable to a new value by the user based upon a user desired valueor new research on threshold percentage.

Example 5

A surgical apparatus that uses the foot pedal to toggle betweenautomatic updating of max count value/threshold value, and holding ofthose values.

Example 6

The surgical apparatus of example 5, wherein a first tap of the footpedal holds a value and a second tap of the foot pedal releases a value.

Example 7

The surgical apparatus of example 5, wherein a voice command causes theapparatus to hold a value, and a second voice command causes theapparatus to release a value.

Example 8

A surgical apparatus that includes a temperature sensor in a probe orinstrumentation console configured to automatically compensate for thetemperature drift of the signal when detecting proximity or signalstrength of a material wherein the material or probe are affected bytemperature such that the measured strength at a fixed distance has aninverse relationship, such that the higher the temperature the lower themeasured strength, wherein the relationship is used to assist incalibrating and adjusting the field strength value for detection duringuse, and continuously adjust for the temperature related drift as theprobe temperature could be affected by the temperature of the personbeing examined depending how close the probe tip is to tissue.

Example 9

A surgical apparatus wherein if the temperature sensor detects anabnormally low or high temperature outside of the operating temperaturerange, the processor in the control module is configured to prevent theoperation of the apparatus, wherein the processor is configureddetermine when the temperature is within a usable range and allowoperation of the apparatus, and wherein the processor is configured touse the temperature drift graph to adjust the realtime count value basedon the sensed temperature value.

Example 10

A surgical apparatus comprising an instrumentation console and a probe,wherein the probe is configured to measure a concentration of a tracingagent injected into a patient by placing the probe proximate to aportion of the patients body, and wherein the instrumentation console isconfigured to display a measure value indicating the currently measuredconcentration, and wherein the instrumentation console is configured toreceive a user input and set a threshold value, wherein the thresholdvalue is a configured percentage of the currently measuredconcentration, and wherein the instrumentation console is configured todisplay the threshold value and the currently measured concentrationsimultaneously, and wherein the probe comprises a temperature sensor,and wherein the instrumentation console is configured to determine acurrent temperature of the probe and, where the current temperaturefalls outside of a usable range, disable use of the surgical apparatus,and where the temperature falls within a usable range, use thetemperature to calibrate the currently measured concentration displayedduring use of the probe to account for temperature related drift of themeasured concentration.

Example 11

An apparatus for detecting a locating medium in tissue, the apparatuscomprising: a probe, wherein the probe includes a handle and a detectordisposed on a distal end of the probe; and a console in communicationwith the probe, wherein the console includes a display having a firstgraphical representation and a second graphical representation, whereinthe first graphical representation is configured to depict a countreal-time count based on a signal from the detector, wherein the secondgraphical representation is configured to depict a target count.

Example 12

The apparatus of Example 11, wherein the target count depicted by thesecond graphical representation corresponds to a user selectable targetcount.

Example 13

The apparatus of Example 11, wherein the display further includes athird graphical representation, wherein the third graphicalrepresentation is configured to graphically depict a proportionalrelationship between the real-time count and the target count.

Example 14

The apparatus of any one or more of Examples 11 through 13, wherein thetarget count is configured to be automatically set based on apredetermined percentage of a maximum count detected by the detectorduring a procedure.

Example 15

The apparatus of Example 14, wherein the predetermined percentage is 10%of the maximum count.

Example 16

The apparatus of Example 14, wherein the predetermined percentage isconfigured to be identified by an operator.

Example 17

The apparatus of any one or more of Examples 11 through 16, wherein theconsole further includes a user input, wherein the user input isconfigured to set the target count upon receipt of a command input basedon a predetermined percentage of the real-time count detectedcontemporaneously with the command input.

Example 18

The apparatus of Example 17, wherein the predetermined percentage is 10%of the maximum count.

Example 19

The apparatus of Example 17, wherein the predetermined percentage isconfigured to be identified by an operator.

Example 20

The apparatus of Example 17, wherein the user input includes one or moreof a push button, a foot pedal, and a voice detector.

Example 21

The apparatus of any one or more of Examples 11 through 20, furthercomprising a temperature sensor and a processor, wherein the temperaturesensor is configured to detect an operational temperature, wherein theprocessor is in communication with the temperature sensor and configuredto adjust the signal of the detector to automatically compensate fortemperature drift associated with the signal of the detector.

Example 22

An apparatus for locating lymph nodes, the apparatus comprising: a probehaving a handle and a proximity sensor disposed on a distal end of thehandle, wherein the proximity sensor is configured to sense the strengthof a signal received from a source disposed within tissue; and a userinterface in communication with the probe, wherein the user interfaceincludes a first indicator and a second indicator, wherein the firstindicator is configured to display the signal sensed by the proximitysensor continuously and in real-time, wherein the second indicator isconfigured to display a target value relative to the signal sensed bythe proximity sensor.

Example 23

The apparatus of Example 22, wherein the user interface furthercomprises a third indicator, wherein the third indicator is configuredto provide a visual indication of a difference between the signal sensedby the proximity sensor and the target value.

Example 24

The apparatus of Examples 22 or 23, wherein at least a portion of theuser interface is incorporated into the handle of the probe.

Example 25

The apparatus of any one or more of Examples 22 through 24, wherein theuser interface further includes a threshold button, wherein thethreshold button is configured to initiate a set threshold sequencewhere the target value is set to the signal sensed by the proximitysensor upon initiation of the set threshold sequence reduced by apredetermined amount set by an operator.

Example 26

The apparatus of any one or more of Examples 22 through 24, wherein theuser interface further includes a threshold button, wherein thethreshold button is configured to initiate a set threshold sequencewhere the target value is set to 10% of the signal sensed by theproximity sensor upon initiation of the set threshold sequence.

Example 27

The apparatus any one or more of Examples 22 through 26, wherein thesensor is detachably coupled to the handle.

Example 28

A system, comprising: a hand-held probe including: a detector configuredto generate a signal proportionate to the proximity of concentration ofa tracing medium positioned proximate a portion of the detector, ahandle, wherein the detector extends from a distal end of the handle,and a probe link configured to transmit data associated with the signalgenerated by the detector; and a controller including: a housing, acontroller link disposed within the housing and configured to receivedata from the probe link, a receiver in communication with thecontroller link, and a display in communication with the receiver,wherein the receiver is configured to drive the display to generate afirst indicator and a second indicator on the display based on datareceived from the probe link, wherein the first indicator corresponds toa current signal generated by the detector, wherein the second indicatorcorresponds to a target signal.

Example 29

The system of Example 28, wherein the receiver is configured to generatethe target signal automatically based on calculating 10% of a maximumsignal value generated by the detector during a predetermined period oftime.

Example 30

The system of Example 29, wherein the predetermined period of timecorresponds to either the duration of a procedure or the duration duringwhich an operator input is received by the receiver.

Example 31

The system of any one or more of Examples 28 through 30, furthercomprising a temperature sensor and a processor, wherein the temperaturesensor is configured to detect an operational temperature, wherein theprocessor is in communication with the temperature sensor and configuredto adjust data from the probe link to automatically compensate fortemperature drift of the signal generated by the detector.

The invention claimed is:
 1. An apparatus for detecting a locatingmedium in tissue, the apparatus comprising: (a) a probe, wherein theprobe includes a handle and a detector disposed on a distal end of theprobe; and (b) a console in communication with the probe, wherein theconsole includes a display having a first graphical representation and asecond graphical representation, wherein the first graphicalrepresentation is configured to depict a real-time count based on asignal from the detector, wherein the second graphical representation isconfigured to depict a target count.
 2. The apparatus of claim 1,wherein the target count depicted by the second graphical representationcorresponds to a user selectable target count.
 3. The apparatus of claim1, wherein the display further includes a third graphicalrepresentation, wherein the third graphical representation is configuredto graphically depict a proportional relationship between the real-timecount and the target count.
 4. The apparatus of claim 1, wherein thetarget count is configured to be automatically set based on apredetermined percentage of a maximum count detected by the detectorduring a procedure.
 5. The apparatus of claim 4, wherein thepredetermined percentage is 10% of the maximum count.
 6. The apparatusof claim 4, wherein the predetermined percentage is configured to beidentified by an operator.
 7. The apparatus of claim 1, wherein theconsole further includes a user input, wherein the user input isconfigured to set the target count upon receipt of a command input basedon a predetermined percentage of the real-time count detectedcontemporaneously with the command input.
 8. The apparatus of claim 7,wherein the predetermined percentage is 10% of the maximum count.
 9. Theapparatus of claim 7, wherein the predetermined percentage is configuredto be identified by an operator.
 10. The apparatus of claim 7, whereinthe user input includes one or more of a push button, a foot pedal, anda voice detector.
 11. An apparatus for locating lymph nodes, theapparatus comprising: (a) a probe having a handle and a proximity sensordisposed on a distal end of the handle, wherein the proximity sensor isconfigured to sense the strength of a signal received from a sourcedisposed within tissue; and (b) a user interface in communication withthe probe, wherein the user interface includes a first indicator and asecond indicator, wherein the first indicator is configured to displaythe signal sensed by the proximity sensor continuously and in real-time,wherein the second indicator is configured to display a target valuerelative to the signal sensed by the proximity sensor.
 12. The apparatusof claim 11, wherein the user interface further comprises a thirdindicator, wherein the third indicator is configured to provide a visualindication of a difference between the signal sensed by the proximitysensor and the target value.
 13. The apparatus of claim 11, wherein atleast a portion of the user interface is incorporated into the handle ofthe probe.
 14. The apparatus of claim 11, wherein the user interfacefurther includes a threshold button, wherein the threshold button isconfigured to initiate a set threshold sequence where the target valueis set to the signal sensed by the proximity sensor upon initiation ofthe set threshold sequence reduced by a predetermined amount set by anoperator.
 15. The apparatus of claim 11, wherein the user interfacefurther includes a threshold button, wherein the threshold button isconfigured to initiate a set threshold sequence where the target valueis set to 10% of the signal sensed by the proximity sensor uponinitiation of the set threshold sequence.
 16. The apparatus of claim 11,wherein the sensor is detachably coupled to the handle.
 17. A system,comprising: (a) a hand-held probe including: (i) a detector configuredto generate a signal proportionate to a proximity of concentration of atracing medium positioned proximate a portion of the detector, (ii) ahandle, wherein the detector extends from a distal end of the handle,and (iii) a probe link configured to transmit data associated with thesignal generated by the detector; and (b) a controller including: (i) ahousing, (ii) a controller link disposed within the housing andconfigured to receive data from the probe link, (iii) a receiver incommunication with the controller link, and (iv) a display incommunication with the receiver, wherein the receiver is configured todrive the display to generate a first indicator and a second indicatoron the display based on data received from the probe link, wherein thefirst indicator corresponds to a current signal generated by thedetector, wherein the second indicator corresponds to a target signal.18. The system of claim 17, wherein the receiver is configured togenerate the target signal automatically based on calculating 10% of amaximum signal value generated by the detector during a predeterminedperiod of time.
 19. The system of claim 18, wherein the predeterminedperiod of time corresponds to either the duration of a procedure or theduration during which an operator input is received by the receiver. 20.The system of claim 17, further comprising a temperature sensor and aprocessor, wherein the temperature sensor is configured to detect anoperational temperature, wherein the processor is in communication withthe temperature sensor and configured to adjust data from the probe linkto automatically compensate for temperature drift of the signalgenerated by the detector.